Voluven

Package Leaflet: Information for the User

VOLUVEN, (60 mg + 9 mg)/ml, Solution for Infusion

Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution

Warning

Do not use in case of sepsis (severe generalized infection), renal dysfunction, or in critically ill patients.
Situations in which this product should never be used are listed in section 2.

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is VOLUVEN and what is it used for
• 2. Important information before using VOLUVEN
• 3. How to use VOLUVEN
• 4. Possible side effects
• 5. How to store VOLUVEN
• 6. Package contents and other information

1. What is VOLUVEN and what is it used for

VOLUVEN is a plasma substitute used to restore blood volume due to its loss, when the use of crystalloid products is not sufficient.

2. Important information before using VOLUVEN

When not to use VOLUVEN:

• in patients with severe generalized infection (sepsis);
• in patients with burns;
• in patients with renal failure or undergoing dialysis;
• in patients with cerebral hemorrhage (intracranial or cerebral hemorrhage);
• in critically ill patients (e.g., those in the Intensive Care Unit);
• in patients with too much fluid in the body and have been informed that they have a condition of fluid overload;
• in patients with fluid in the lungs (pulmonary edema);
• in dehydrated patients;
• in patients with a significant increase in sodium levels in the blood;
• in patients with severe liver dysfunction;
• in patients with severe heart failure;
• in patients with severe coagulation disorders;
• in patients after organ transplantation.

Warnings and precautions

Before starting treatment with VOLUVEN, tell your doctor if you have:

• liver dysfunction;
• heart and circulation problems;
• coagulation disorders;
• kidney dysfunction.

Due to the risk of allergic reactions(anaphylactic/anaphylactoid), your doctor will closely monitor you to observe early signs of an allergic reaction after administration of this medicine.
Surgical procedures and injuries:
Your doctor will consider whether this medicine is suitable for you.
Your doctor will carefully determine the dose of VOLUVEN to avoid fluid overload. This will be especially important in patients with lung, heart, or circulation problems.
Nursing staff will also take measures to monitor the patient's fluid balance, electrolyte levels, and kidney function. If necessary, additional medications may be administered.
Additionally, the patient will be ensured to receive sufficient fluids.
VOLUVEN is contraindicated in patients with renal dysfunction or kidney damage requiring dialysis.
If renal dysfunction occurs during treatment:
If your doctor observes the first symptoms of renal dysfunction, they will stop administering this medicine. Additionally, there may be a need for monitoring kidney function for up to 90 days.
If VOLUVEN is administered repeatedly, your doctor will monitor blood coagulation, bleeding time, and other functions. In case of coagulopathy, your doctor will discontinue the administration of this medicine.
The use of this medicine is not recommended in patients undergoing open-heart surgery, connected to heart-lung machines that support blood pumping during the procedure.

Children

Data on the use of VOLUVEN in children are limited. The use of hydroxyethyl starch (HES) is not recommended in this age group.

VOLUVEN and other medicines

Tell your doctor or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
So far, no interactions between VOLUVEN and other medicines have been reported.

VOLUVEN with food and drink

There is no data on the negative impact of VOLUVEN when used with food or drink.

Pregnancy, breastfeeding, and fertility

There is no data on the use of VOLUVEN in pregnant or breastfeeding women. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonic or fetal development, childbirth, or postnatal development. No teratogenic effects have been observed.
VOLUVEN may be administered to pregnant or breastfeeding women if, in the doctor's judgment, the potential benefit to the mother outweighs the potential risk to the child.
It is not known whether hydroxyethyl starch passes into breast milk. The passage of hydroxyethyl starch into breast milk has not been studied in animals. If a patient is breastfeeding, the decision to continue or discontinue breastfeeding or to continue or discontinue treatment with VOLUVEN solution should be made by the doctor, taking into account both the benefits of breastfeeding for the child and the benefits of VOLUVEN treatment for the patient.

Driving and using machines

VOLUVEN has no effect on the ability to drive or use machines.

3. How to use VOLUVEN

VOLUVEN is administered by a doctor or under the direct supervision of a doctor, who carefully controls the amount of medicine administered.
Method of administration
The medicine is administered by intravenous infusion (drip) with a rate and dose size dependent on specific requirements, the condition being treated, and taking into account the maximum dose.
Do not exceed the maximum daily dose.
Dosage
Your doctor will decide on the appropriate dose for you to receive.

The doctor will use the smallest effective dose and will not administer the infusion of VOLUVEN for more than 24 hours.

The maximum daily dose of VOLUVEN is 30 ml/kg body weight.

The initial 10-20 ml should be administered slowly, with close monitoring of the patient to quickly detect any signs of anaphylactic/anaphylactoid reaction.

Use in children

There is limited experience with the use of this medicine in children. The use of this medicine is not recommended in children.

Overdose of VOLUVEN

As with all plasma substitutes, if a patient receives too much VOLUVEN, it may cause circulatory overload, which can lead to, for example, fluid accumulation in the patient's lungs (pulmonary edema).
Your doctor will ensure that you receive the correct dose of VOLUVEN. However, different patients require different doses of the medicine. If too much medicine is administered, your doctor may immediately stop the administration of the medicine and, if necessary, administer a medicine that removes excess fluid from the body (diuretic).
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Blood and lymphatic system disorders

Rarely:after administration of hydroxyethyl starch, dose-dependent coagulation disorders may occur.

Immune system disorders

Rarely:medicines containing hydroxyethyl starch may lead to severe allergic reactions (skin redness, mild flu-like symptoms, low and high heart rate, throat swelling, and breathing difficulties, non-cardiogenic pulmonary edema).

Skin and subcutaneous tissue disorders

Often:itching (during long-term use of high doses of the medicine).

Diagnostic tests

Often:during the administration of hydroxyethyl starch, the amylase activity in the blood serum may increase, which can interfere with the diagnosis of pancreatitis. However, this should not be misinterpreted as pancreatitis.
Other side effects related to blood dilution, such as prolonged bleeding time, resulting from the use of high doses.
Frequency not known(frequency cannot be estimated from the available data):

• liver dysfunction;
• kidney dysfunction.

Reporting side effects
If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store VOLUVEN

Store in a place out of sight and reach of children.
Store at a temperature below 25°C. Do not freeze.
Do not use VOLUVEN after the expiry date stated on the label. The expiry date refers to the last day of the month.

Your doctor or nurse will check if the solution is clear, free from particles, and the packaging is undamaged, and if the outer bag has been removed from the polyolefin bag (freeflex) before use.
The solution should be used immediately after opening, and any unused solution or waste should be disposed of. For single use only.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What VOLUVEN contains

1000 ml of the solution for infusion contains:

Active substances:

hydroxyethyl starch
60 g

• degree of substitution: 0.38 - 0.45
• average molecular weight: 130,000 Da (derived from corn starch)

sodium chloride
9 g
Electrolytes:
Na
154 mmol/l
Cl
154 mmol/l
Theoretical osmolality
308 mOsmol/l
Acidity of the solution
<1.0 mmol NaOH/l
pH
4.0 – 5.5
Other ingredients are:sodium hydroxide, hydrochloric acid 25%, water for injections.

What VOLUVEN looks like and package contents

The medicine is a sterile, clear to slightly opalescent, colorless to slightly yellowish solution.
Available in:

• polyolefin bags of the freeflextype: 250 ml, 500 ml;
• polyethylene bottles of the bottlepack type: 250 ml, 500 ml;
• polyethylene containers KabiPac with a cap: 1x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Kabi Deutschland GmbH
Werk Friedberg
D-61169 Friedberg
Freseniusstrasse 1
Germany
Fresenius Kabi Polska Sp. z o.o.
Infusion Fluids Factory
ul. Sienkiewicza 25
99-300 Kutno
To obtain more detailed information, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
Date of last revision of the package leaflet:05.11.2023

Information intended for healthcare professionals only:

The use of hydroxyethyl starch (HES) should be limited to the initial period of fluid resuscitation, with a maximum administration period of 24 hours.

The maximum daily dose is 30 ml/kg body weight of VOLUVEN.
Use the smallest effective dose. Treatment should be carried out with continuous monitoring of hemodynamics to stop the infusion as soon as the appropriate hemodynamic parameters are achieved. Do not exceed the maximum recommended daily dose.
Administer the initial 10-20 ml slowly, with close monitoring of the patient to quickly detect any signs of anaphylactic/anaphylactoid reaction.
If an anaphylactic/anaphylactoid reaction occurs, stop the infusion immediately and initiate appropriate treatment.
The duration of treatment depends on:

• the volume of blood lost by the patient;
• blood pressure;
• blood dilution and its components (platelets, red blood cells, etc.).

Children and adolescents
Data on the use of VOLUVEN in children are limited, so the use of HES is not recommended in this age group.
For single use only.
Use immediately after opening the bottle, bag, or container.
Any unused solution or waste should be disposed of in accordance with local regulations.
Only use the solution that is clear, free from particles, and has undamaged packaging.
Before use, remove the protective outer bag from the polyolefin bag (freeflex).